Consensus Statement Supplement Update

San Francisco – November 10, 2015 – SmartTots today released a supplement to their recently updated Consensus Statement. Immediately following the announcement of the secondary outcomes from the clinical trial, General Anesthesia Compared to Spinal Anesthesia (the GAS Study), SmartTots convened more than 30 experts in anesthesia, pediatric medicine and neuroscience to discuss the trial’s early findings and consider their significance. The Consensus Statement Supplement was developed as a result of this meeting.

The GAS Study is the first prospective clinical trial to explore the effects of anesthetics on the developing brain in humans. The secondary outcome data, based on 532 subjects, indicated that children who had undergone either general anesthesia or regional anesthesia in a surgical procedure lasting less than 1 hour showed no difference in cognitive development at the 2-year timepoint.

While acknowledging the importance of the research, SmartTots is emphasizing that these findings represent secondary outcomes. The primary outcome of the GAS Study will be performance on a test of cognition at age 5, and may be able to detect changes not present at age 2.

While the results are welcome and encouraging, important questions still remain. It is too soon to say with certainty that a single short duration of exposure is safe. SmartTots continues to work with investigators to design and promote additional research. In the meantime, SmartTots does not recommend putting off needed surgery or procedures requiring anesthetics or sedatives – or conducting needed treatments without pain medication. SmartTots urges health care providers and parents to discuss the risks, benefits and timing of any treatment, and advises weighing the benefits of any elective procedure against potential risks from anesthesia and sedation.